A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia
| Tracking Information | |||||
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| First Received Date ICMJE | March 6, 2012 | ||||
| Last Updated Date | March 11, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia [ Time Frame: Participants will be followed for postoperative period, approximate 1 week through chart review. ] [ Designated as safety issue: No ] We collect laboratory data of the patients which were underwent at preoperative period and during postoperative periods. The laboratory data includes hemoglobin (Hb), hematocrit (Hct), platelet, prothrombin time (PT), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine (Cr) and estimated glomerular filtration rate (eGFR) which was calculated by the Modification of Diet in Renal Disease (MDRD) formula with age, gender, race, and serum creatinine as variables. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01549990 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Living-donor kidney transplantation has been considered as the best treatment for patients with end-stage renal disease (ESRD). Kidney donation from living donors has been performed widely under their noble humanity and a belief that donation would not harm the donor. Although the overall evidences proposed that living kidney donor have medical outcomes similar to those in general population, several reports have demonstrated the potential risks for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be concentrated on ensuring their safety and preserving the function of their remained kidney during anesthesia maintenance. Inhaled anesthetics have been frequently used for the induction and maintenance of general anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride, which may be directly nephrotoxic through impairments of renal concentrating ability. The typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The defluorination of sevoflurane can results in increased serum inorganic fluoride ion concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human. On the other hand, desflurane is extremely resistant to defluorination, and desflurane does not appear to be nephrotoxic. The inhaled anesthetics which are currently used in general anesthesia have no clinical evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially in the patients who one kidney is donated. The purpose of the current retrospective, single center study was to evaluate and compare postoperative renal function of living kidney donor after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based recommendations of proper inhaled anesthetics for anesthesia of living kidney donor. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | From January 2006 through December 2011, donors who went through nephrectomy for kidney donation |
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| Condition ICMJE | Nephrectomy,Kidney Donation | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Vats HS, Rayhill SC, Thomas CP. Early postnephrectomy donor renal function: laparoscopic versus open procedure. Transplantation. 2005 Mar 15;79(5):609-12. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 236 | ||||
| Estimated Completion Date | October 2012 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01549990 | ||||
| Other Study ID Numbers ICMJE | 4-2012-0012 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yonsei University | ||||
| Study Sponsor ICMJE | Yonsei University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Yonsei University | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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